Cleared Special

K071985 - GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND

K071985 is the FDA 510(k) clearance for GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND by General Electric Co.. It is a Class 2 Radiology device (product code IYN) cleared through the Special 510(k) pathway after a 29-day FDA review.

K071985 · General Electric Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
29d
Days
Class 2
Risk

K071985 is an FDA 510(k) clearance for the GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by General Electric Co. (Wauwatosa, US). The FDA issued a Cleared decision on August 17, 2007 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all General Electric Co. devices

Submission Details

510(k) Number K071985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2007
Decision Date August 17, 2007
Days to Decision 29 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 789
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K071985.
APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM
K080160 · Toshiba America Medical Systems, In.C · Feb 2008
GE LOGIQ P6
K073297 · General Electric Co. · Dec 2007
MODIFICATION TO GE LOGIQ A3
K072075 · General Electric Co. · Aug 2007
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0
K072000 · Toshiba America Medical Systems, In.C · Jul 2007
ACUSON X150 ULTRASOUND SYSTEM
K070576 · Siemens Medical Solutions USA, Inc. · Mar 2007
OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER
K063683 · Olympus Medical Systems Corporation · Feb 2007